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GDFSE 0164 Sample Bill Update  Form

GDFSE 0164 Sample Bill Update Form

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Instructions and help about GDFSE 0164 Sample Bill Update

hello my name is Audrey Turley and I am with Nelson Laboratories I have worked with Nelson Laboratories for over 20 years and working in biocompatibility for the last 15 years today we are going to learn about satisfying ISO 18 562 and USSD a biocompatibility requirements for breathing gas pathway devices I'd like to get started by a brief introduction to the standards I'm going to use for my presentation I'm going to use and discuss the 18 562 this is a vertical standard that goes along with up to 10 a nine three suite of testing so ISO 1009 three covers biocompatibility for medical devices it's a very broad application of biocompatibility considerations for all medical devices and eighteen 562 is what we would consider a vertical standard that helps us assess the additional risks that are inherent with gas pathway devices we will also discuss some information that is found in the US FDA guidance document on the use and interpretation of ISO 10 993 a bi

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